Clinical Trial 22279

• Overview

  Study Title:

  A Phase 1a/b Open-Label Master Study of PF-07799544 as a Single-Agent and in Combination with Other Targeted Agents in Participants with Advanced Solid Tumors

  Summary:

  The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) administered as a single agent and in combination with other study medications in people with solid tumors. This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer.

  Objective:

  Phase 1a Primary To assess the safety and tolerability of PF-07799544 at increasing dose levels and to estimate the MTD and select the MTDM/RDEM as a single agent in participants with advanced solid tumors. Phase 1a Secondary To characterize the single and multiple-dose PK of PF-07799544 as a single agent

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  PF-07284890 (); PF-07799544 (); PF-0779993 ()

• Inclusion Criteria

  • Participants must be 18 years of age or older
  • Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation
  • Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation
  • For Substudy A and B, histological or cytological diagnosis of advanced/metastatic melanoma
  • For Substudy A and B, measurable disease by RECIST version 1.1
  • For Substudy A, evidence of a BRAF V600 mutation in tumor tissue and/or blood
  • For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II alteration in tumor tissue and/or blood

• Exclusion Criteria

  • Brain metastasis larger than 4 cm
  • Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
  • For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)

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